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1. (WO2018223322) CIRCULAR STAPLING INSTRUMENT
Document

Description

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Claims

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Drawings

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Description

Title of Invention : CIRCULAR STAPLING INSTRUMENT

BACKGROUND

[0001]
1. Technical Field
[0002]
The present disclosure relates to a surgical stapling instrument and, more particularly, relates to a circular stapling instrument adapted to deliver three rows of staples in connection with a surgical anastomosis procedure.
[0003]
2. Background of Related Art
[0004]
Anastomosis is the surgical joining of separate hollow organ sections. Typically, an anastomosis procedure follows surgery in which a diseased or defective section of hollow tissue is removed and the remaining end sections are to be joined. Depending on the desired anastomosis procedure, the end sections may be joined by either end-to-end, end-to-side, or side-to-side organ reconstruction methods.
[0005]
In a circular anastomosis procedure, the two ends of the organ sections are joined by means of a stapling instrument which drives a circular array of staples through the end section of each organ section and simultaneously cores any tissue interior of the driven circular array of staples to free the tubular passage. An example of an instrument for performing circular anastomosis of tissue is disclosed in commonly assigned U. S. Patent Publication No. 20150014393 to Milliman, the entire contents of which is incorporated by reference herein.
[0006]
Typically, these instruments include an elongated shaft having a handle portion at a proximal end to actuate the instrument and a staple holding component disposed at a distal end. An anvil assembly including an anvil rod with attached anvil head is mounted to the distal end of the instrument adjacent the staple holding component. Opposed end portions of tissue of the hollow organ (s) to be stapled are clamped between the anvil head and the staple holding component. The clamped tissue is stapled by driving one or more staples from the staple holding component so that the ends of the staples pass through the tissue and are deformed by the anvil head. An annular knife is advanced to core tissue within the hollow organ to free a tubular passage within the organ. Generally, both the actuation of the staple forming mechanism and the advancement of the knife occur simultaneously.
[0007]
SUMMARY
[0008]
Accordingly, the present disclosure is directed to further improvements in circular stapling instruments. In one embodiment, a circular stapling instrument includes a handle, an elongate body extending from the handle, a cartridge housing mounted to the elongate body and defining a central housing axis, first inner, second middle and third outer circular rows of staples disposed within the cartridge housing and concentrically mounted about the central housing axis, a staple pusher at least partially disposed within the cartridge housing and configured for movement through a firing stroke to eject the staples, and an anvil assembly having an anvil rod configured for coupling relative to the cartridge housing and an anvil head configured for at least partially deforming the staples.
[0009]
In embodiments, the staple pusher includes first inner, second middle and third outer circular rows of pusher fingers in registration with the respective first inner, second middle and third outer circular rows of staples. Each pusher finger is configured to engage an individual staple to eject the individual staple for deformation by the anvil head. In some embodiments, the pusher fingers of the first inner, second middle and third outer circular rows of pusher fingers longitudinally extend along the central housing axis for respective first, second and third pusher distances. The first pusher distance is greater than the second pusher distance and the second pusher distance is greater than the third pusher distance.
[0010]
In certain embodiments, the staples of the first inner, second middle and third outer circular rows of staples define respective first, second and third longitudinal staple lengths. The first longitudinal staple length is less than the second longitudinal staple length and the second longitudinal staple length is less than the third longitudinal staple length. In embodiments, each staple defines a staple backspan and opposed legs having remote ends. The remote ends of the staples of each of the first inner, second middle and third outer circular rows of staples are disposed at a same longitudinal position with respect to the central housing axis prior to movement of the staple pusher through the firing stroke.
[0011]
In embodiments, a staple retainer is mounted to the cartridge housing. The staple retainer includes first inner, second middle and third outer staple retainer openings to at least partially accommodate respective staples of the first inner, second middle and third outer circular rows of staples. In some embodiments, the staple retainer includes an outer contacting surface adjacent the anvil head whereby the outer contacting surface slopes in a proximal direction toward a periphery of the staple retainer.
[0012]
In certain embodiments, the anvil head includes first inner, second middle and third outer staple forming pockets in registration with respective staples of the first, second and third circular rows of staples.
[0013]
In another embodiment, a circular stapling instrument includes a handle, an elongate body extending from the handle, a cartridge housing mounted to the elongate body and defining a central housing axis, first and second circular rows of staples disposed within the cartridge housing and concentrically mounted about the central housing axis, and a staple pusher at least partially disposed within the cartridge housing. The staple pusher includes first and second circular rows of pusher fingers concentrically arranged with respect to the central housing axis and in registration with the respective first and second circular rows of staples. The pusher fingers of the first and second rows longitudinally extend along the central housing axis for respective first and second pusher distances. The first pusher distance is greater than the second pusher distance. In embodiments, the first and second rows of staples define respective first and second staple lengths where the first staple length is less than the second staple length. In some embodiments, the first circular row of pusher fingers and the first circular row of staples are disposed radially inward of the second circular row of pusher fingers and the second circular row of staples.
[0014]
The surgical stapling instrument of the present disclosure may deliver two or more circular rows of staples to end segments of tubular organs to establish an anastomosis with a more stable connection, thus increasing burst pressure while reducing hemostatic leakage at the juncture of the anastomosis and the healthy tissue. The pusher assembly incorporates pusher members of different lengths and in conjunction with the use of staples of different lengths ensures that sufficient organ tissue is captured along both the outermost periphery of the organ tissue and at locations radial inward of the outermost periphery.
[0015]
Other advantages of the present disclosure will become apparent from the following description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016]
Various aspects of the present disclosure are described hereinbelow with reference to the drawings, which are incorporated in and constitute a part of this specification, wherein:
[0017]
FIG. 1 is a perspective view of the circular stapling apparatus in accordance with the present disclosure illustrating the handle assembly, the elongate body extending from the handle assembly and the end effector assembly;
[0018]
FIG. 2 is an exploded perspective view of the circular stapling apparatus illustrating the end effector assembly separated from the elongate body;
[0019]
FIG. 3 is a perspective view of the staple cartridge mechanism of the end effector assembly;
[0020]
FIG. 4 is an axial plan view of the staple retainer of the staple cartridge mechanism;
[0021]
FIG. 5 is a perspective view of the staple retainer and the cartridge housing of the staple cartridge mechanism;
[0022]
FIG. 6 is a side elevation view of the pusher assembly of the staple cartridge mechanism;
[0023]
FIG. 7 is an axial plan view of the pusher assembly;
[0024]
FIG. 8 is a perspective view in cross-section of the pusher assembly;
[0025]
FIG. 9 is a side elevation view of surgical staples of the staple cartridge mechanism;
[0026]
FIG. 10 is a perspective view of the pusher assembly with mounted surgical staples;
[0027]
FIG. 11 is a view illustrating the anvil mechanism and the staple cartridge mechanism positioned within end sections of tubular organs to create an anastomosis;
[0028]
FIG. 12 is a cross-sectional view taken along the lines 12-12 of FIG. 11;
[0029]
FIG. 13 is an axial view illustrating the three circular rows of staples deformed against the anvil head of the anvil mechanism; and
[0030]
FIG. 14 is a view illustrating the anastomosis created with the circular stapling instrument.

DETAILED DESCRIPTION

[0031]
Embodiments of the present disclosure are now described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein, the term “clinician” refers to a doctor, a nurse, or any other care provider and may include support personnel. Throughout this description, the term “proximal” refers to that portion of the device or component thereof that is closest to the clinician and the term “distal” refers to that portion of the device or component thereof that is farthest from the clinician.
[0032]
Referring initially to FIGS. 1-2, a circular surgical stapling instrument is illustrated, and is generally designated as reference numeral 10. The stapling instrument 10 may be adapted for reuse or alternatively is disposable after a single use. The stapling instrument 10 includes a handle assembly 100, an elongate body 200 extending from the handle assembly 100, and an end effector assembly 300. The handle assembly 100 includes a rotatable approximating member 102 and a pivotable trigger 104 that are operatively coupled to mechanisms supported within the elongate body 200 to respectively effectuate approximation of components of the end effector assembly 300 and firing of the circular stapling instrument 10. In some embodiments, the elongate body 200 has a linear shape along at least a portion of its length, and in other embodiments, the elongate body 200 has a curved shape along at least a portion of its length. The end effector assembly 300 may be provided as a removable and replaceable assembly that is releasably secured relative to the elongate body 200. In the alternative, the end effector assembly 300 may be permanently secured to the elongate body 200.
[0033]
For a detailed discussion of the construction and operation of an exemplary circular stapling instrument, reference may be made to commonly assigned U.S. Patent Publication No. 20150014393 to Milliman, the entire contents of which has been incorporated herein by reference.
[0034]
With reference to FIGS. 3-5, in conjunction with FIG. 2, the end effector assembly 300 will be discussed. The effector assembly 300 includes a staple cartridge mechanism 302, which, in embodiments, is releasably mountable relative to the elongate body 200 and an anvil mechanism 304 which, in turn, is releasably mountable with respect to the staple cartridge mechanism 302. The staple cartridge mechanism 302 includes a cartridge housing 306 defining a central housing axis “k” , a pusher assembly 308 at least partially disposed within the cartridge housing 306 and a circular knife 310 which is mounted within the pusher assembly 308. Also disposed within the cartridge housing 306 is a staple retainer 312 which accommodates a plurality of staples (not shown) .
[0035]
Disposed within the interior of the cartridge housing 306 in general alignment with the central housing axis “k” is an inner anvil receptacle 314. The inner anvil receptacle 314 is generally cylindrical in configuration and defines an internal surface having a plurality of splines 316. The inner anvil receptacle 314 is mounted within the cartridge housing 306 via ribs 318 extending outwardly from the inner receptacle 314 and coupled to the wall of the cartridge housing 306. The inner anvil receptacle 314 may accommodate a trocar 400 (FIG. 2) which extends through the anvil receptacle 314 and is operatively coupled to the approximating member 102 of the handle assembly 100. The trocar 400 may assist in mounting the anvil mechanism 304 relative to the staple cartridge mechanism 302. The cartridge housing 306 including the inner anvil receptacle 314 and the ribs 318 may be monolithically formed of a suitable polymeric material. The cartridge housing further includes diametrically opposed tabs 320 which facilitate securement to the elongate body 200.
[0036]
The cartridge housing 306 further includes at least one positioning slot 322 in its outer surface coterminous with the end of the cartridge housing 306 and at least one, e.g., four mounting openings 324 radially spaced with respect to the central housing axis “k” . The positioning slot 322 and mounting openings 324 facilitate securing and mounting of the staple retainer 312 relative to the cartridge housing 306. An irrigation hole 326 may extend through the wall of the cartridge housing 306 for supplying an irrigant to the surgical site.
[0037]
With continued reference to FIGS. 3-5, the staple retainer 312 is generally annular in configuration and is at least partially received within the cartridge housing 306. In embodiments, the staple retainer 312 includes a positioning rib 328 which is received within the positioning slot 322 in the cartridge housing 306 to align the staple retainer 312 relative to the cartridge housing 306 and to the pusher assembly 308. The staple retainer 312 further includes at least one, e.g., four mounting snaps 330 which are received within the mounting openings 324 of the cartridge housing 306 to secure the components.
[0038]
The staple retainer 312 includes at least one annular, e.g., circular, row of staple receiving openings 332. In embodiments, the staple retainer 312 includes first (inner) , second (middle) and third (outer) circular rows 332a, 332b, 332c of individual openings 332 concentrically or coaxially arranged about the central housing axis “k” . The staple receiving openings 332 each accommodate an individual staple. In embodiments, the individual openings 332 of the first and third rows 332a, 332c are radially aligned while the individual openings 332 of the second row 332b are radially displaced relative to the first and third rows 332a, 332c. Other arrangements are also envisioned. The staple retainer 312 also includes a sloped or inclined tissue contacting surface 334 tapering downwardly (e.g., proximally) from the interior of the staple retainer 312 toward the periphery of the retainer 312. The slope of the inclined tissue contacting surface 334 may range from about 1° to about 15° relative to a plane orthogonal to the central housing axis “k” . The significance of the sloped arrangement of the tissue contacting surface 334 will be discussed in greater detail hereinbelow.
[0039]
Referring now to FIGS. 6-8, the pusher assembly 308 will be discussed. The pusher assembly 308 includes pusher adapter 336 and a pusher 338 coupled to the pusher adapter 336. The pusher adapter 336 and/or the pusher 338 are configured for operable engagement with a drive member (not shown) extending through the elongate body 200, which, in turn, is coupled to the trigger 104 of the handle assembly 100. Actuation of the trigger 104 causes translating movement of the pusher assembly 308. The pusher assembly 308 includes three circular rows of individual pusher fingers 340 concentrically arranged with respect to the central housing axis “k” . The three circular rows include a first (inner) circular row 340a of pusher fingers, a second (middle) circular row 340b of pusher fingers and a third (outer) circular row 340c of pusher fingers. The first, second and third rows 340a, 340b, 340c of pusher fingers 340 are in alignment or registration with the first (inner) , second (middle) and third (outer) circular rows of individual openings 332a, 332b, 332c of the staple retainer 312. The pusher fingers 340 of the inner and outer circular rows 340a, 340c may be in radial alignment while the pusher fingers 340 of the middle circular row 340b may be radially offset relative to the remaining rows 340a, 340c. Other arrangements are also envisioned.
[0040]
As best depicted in FIGS. 7-8, the pusher fingers 340 of the first (inner) , second (middle) and third (outer) circular rows 340a, 340b, 340c longitudinally extend along the central housing axis “k” for respective first, second and third pusher distances “d1” , “d2” , “d3” . The first pusher distance “d1” of the first (inner) circular row 340a of pusher fingers 340 is greater than the second pusher distance “d2” of the second (middle) circular row 340b of pusher fingers 340. The second pusher distance “d2” of the second (middle) circular row 340b of pusher fingers 340 is greater than the third pusher distance “d3” of the third (outer) row 340c of pusher fingers 340. The different distances of the pusher fingers 340 cooperate with the staples to effectively secure end portions of tissue together during the anastomosis procedure.
[0041]
FIG. 9 illustrates the three different size staples 342 for use with the instrument 10. The staples 342 are mounted in the staple retainer 312. Each staple 342 includes a backspan 344 and opposed legs 346 extending from the backspan 344 and defining remote ends 348. The shortest, middle and longest staples 342 may have respective lengths of 3mm, 3.5mm, 4.0mm or alternatively, may have respective lengths of 4mm, 4.5mm, 5.0 mm. As best depicted in FIG. 10, the longest, middle and shortest staples 342 in length are respectively mounted to the third (outer) row 340c of the pusher fingers 340, the second (middle) row 340b of the pusher fingers 340 and the first (inner) row 340a of the pusher fingers 340. In FIG. 10, the staple retainer 312 is not shown for illustrative purposes. Thus, upon mounting of the staples 342 to their respective fingers, the remote ends 348 of the opposed legs 346 of the staples 342 are generally at the same longitudinal position. This ensures that the staples 342 when deformed are uniformly distributed about the anastomosis site. The mounted staples define a first (inner) , second (middle) and third (outer) circular rows 342a, 342b, 342c of surgical staples.
[0042]
The aforedescribed use of different size staples 342 with pusher fingers 340 of different lengths provides other advantages in the anastomosis procedure. For example, by positioning the longer outer staples adjacent the third (outer) row 340c of the pusher fingers 340, the outer staples 342 can accommodate a greater or larger volume or tissue overlap adjacent the connected organs. The presence of the larger staples 342 at the periphery of the anastomosis may provide a more stable connection thus increasing burst pressure while reducing hemostatic leakage at the juncture of the anastomosis and the healthy tissue. The smaller staples 342 capture the interior tissue of the anastomosis sufficient to maintain the integrity of the anastomosis even in the event of failure or misapplication of the longer outer staple 342. The shorter size staples also may reduce the amount force required to advance the pusher assembly 308 through the firing stroke.
[0043]
The use of the circular stapling instrument 10 for performing an anastomosis of end sections of tubular organs will be discussed. If not already connected, the staple cartridge mechanism 302 is mounted to the elongate body 200 by alignment of the tabs 320 of the cartridge housing 306 with the corresponding slots 202 of the elongate body 200 (FIG. 2) . The mounting of the staple cartridge mechanism 302 also couples the pusher assembly 308 and the knife 310 with respective drive (s) within the elongate body 200 which are coupled to at least the trigger 104 of the handle assembly 100. The anvil mechanism 304 is positioned within a first tubular organ and the organ may be secured about the anvil head 350 with a purse string suture or the like. The circular stapling instrument 10 with mounted staple cartridge mechanism 302 is positioned within a second tubular organ. The anvil rod 352 (FIG. 2) is mounted to the inner anvil receptacle 314 of the cartridge housing 306 to couple the anvil mechanism 304 to the staple cartridge mechanism 302. The splines 316 within the inner anvil receptacle 314 may cooperate with splines on the exterior of the anvil rod 352 to align the staple cartridge mechanism 302 with the anvil mechanism 304. In embodiments, the anvil rod 352 also may be positioned about the trocar 400 (FIG. 2) , and is releasably secured to the trocar 400 via cooperating structure between the two components.
[0044]
With reference to FIG. 11, the anvil head 350 is approximated relative to the cartridge housing 306 through manipulation of the approximating member 102 of the handle assembly 100 to capture the end portions of the tubular organs “o”between the anvil head 350 and the tissue contacting surface 334 of the staple retainer 312. FIG. 12 illustrates the anvil head 350 and the tissue contacting surface 334 in an approximated condition. In FIG. 12, the tissue is removed for clarity purposes. As shown, the first pusher distance of the first (inner) circular row 340a of pusher fingers 340 is greater than the second pusher distance of the second (middle) circular row 340b of pusher fingers 340 and the second pusher distance of the second (middle) circular row 340b of pusher fingers 340 is greater than the third pusher distance of the third (outer) row 340c of pusher fingers 340. FIG. 12 also illustrates the different size staples 342 mounted to each pusher 340 of the first (inner) , second (middle) and third (outer) rows 340a, 340b, 340c and the longitudinal alignment of the remote ends 348 of the staples 342. Also depicted in FIG. 12 is the varied tissue gap created by the inclined tissue contacting surface 334 of the staple retainer 312, i.e., the gap between the anvil head 350 and the tissue contacting surface 334 increases from the center of the anvil head 350 to the periphery of the anvil head 350. This arrangement captures a greater length of organ tissue with the longer staples 342 adjacent the third (outer) row 340c of pusher fingers 340 upon firing of the pusher assembly 308, which enhances the anastomosis procedure by providing a more stable connection of the organ tissues along the outermost periphery of the organ tissue. FIG. 12 also depicts the first inner, second middle and third outer staple forming pockets 354a, 354b, 354c of the anvil head 350, which are respectively in registration with the staples 342 of the first, second and third circular rows of staples 342a, 342b, 342c.
[0045]
The trigger 104 is actuated to move the pusher assembly 308 through a firing stroke and also, in embodiments, advances the knife 310 to core tissue. FIG. 13 illustrates the circular rows of staples 342 crimped or deformed via first inner, second middle and third outer staple forming pockets 354a, 354b, 354c of the anvil head 350. FIG. 14 depicts the anastomosis created the tubular organs.
[0046]
While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Any combination of the above embodiments is also envisioned and is within the scope of the appended claims. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope of the claims appended hereto.

Claims

[Claim 1]
A circular stapling instrument, which comprises: a handle: an elongate body extending from the handle; a cartridge housing mounted to the elongate body and defining a central housing axis; first inner, second middle and third outer circular rows of staples disposed within the cartridge housing and concentrically mounted about the central housing axis; a staple pusher at least partially disposed within the cartridge housing, the staple pusher configured for movement through a firing stroke to eject the staples; and an anvil assembly including an anvil rod configured for coupling relative to the cartridge housing and an anvil head configured for at least partially deforming the staples.
[Claim 2]
The circular stapling instrument according to claim 1 wherein the staple pusher includes first inner, second middle and third outer circular rows of pusher fingers in registration with the respective first inner, second middle and third outer circular rows of staples, each pusher finger configured to engage an individual staple to eject the individual staple for deforming by the anvil head.
[Claim 3]
The circular stapling instrument according to claim 2 wherein the pusher fingers of the first inner, second middle and third outer circular rows of pusher fingers longitudinally extend along the central housing axis for respective first, second and third pusher distances, the first pusher distance being greater than the second pusher distance and the second pusher distance being greater than the third pusher distance.
[Claim 4]
The circular stapling instrument according to claim 3 wherein the staples of the first inner, second middle and third outer circular rows of staples define respective first, second and third longitudinal staple lengths, the first longitudinal staple length being less than the second longitudinal staple length and the second longitudinal staple length being less than the third longitudinal staple length.
[Claim 5]
The circular stapling instrument according to claim 4 wherein each staple defines a staple backspan and opposed legs having remote ends, the remote ends of the staples of each of the first inner, second middle and third outer circular rows of staples being disposed at a same longitudinal position with respect to the central housing axis prior to movement of the staple pusher through the firing stroke.
[Claim 6]
The circular stapling instrument according to claim 4 including a staple retainer mounted to the cartridge housing, the staple retainer including first inner, second middle and third outer staple retainer openings to at least partially accommodate respective staples of the first inner, second middle and third outer circular rows of staples.
[Claim 7]
The circular stapling instrument according to claim 6 wherein the staple retainer includes an outer contacting surface adjacent the anvil head, the outer contacting surface sloping in a proximal direction toward a periphery of the staple retainer.
[Claim 8]
The circular stapling instrument according to claim 2 wherein the anvil head includes first inner, second middle and third outer staple forming pockets in registration with respective staples of the first, second and third circular rows of staples.
[Claim 9]
A circular stapling instrument, which comprises: a handle: an elongate body extending from the handle; a cartridge housing mounted to the elongate body and defining a central housing axis; first and second circular rows of staples disposed within the cartridge housing and concentrically mounted about the central housing axis; and a staple pusher at least partially disposed within the cartridge housing, the staple pusher including first and second circular rows of pusher fingers concentrically arranged with respect to the central housing and in registration with the respective first and second circular rows of staples, the pusher fingers of the first and second rows longitudinally extending along the central housing axis for respective first and second pusher distances, the first pusher distance being greater than the second pusher distance.
[Claim 10]
The circular stapling instrument according to claim 9 wherein the first and second rows of staples define respective first and second staple lengths, the first staple length being less than the second staple length.
[Claim 11]
The circular stapling instrument according to claim 10 wherein the first circular row of pusher fingers and the first circular row of staples are disposed radial inward of the second circular row of pusher fingers and the second circular row of staples.

Drawings

[ Fig. 0001]  
[ Fig. 0002]  
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[ Fig. 0006]  
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[ Fig. 0011]